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Monoclonal Antibodies

Vudalimab for Advanced Gynecologic and Genitourinary Cancers

Phase 2
Recruiting
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cancer must have progressed after treatment with all approved and medically appropriate therapies or have no appropriate available therapies
Histologically confirmed diagnosis of specific tumor types with additional clinical/pathologic confirmation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test if XmAb20717 is safe and effective in treating patients with certain advanced gynecologic or genitourinary cancers.

Who is the study for?
This trial is for adults with certain advanced gynecologic and genitourinary cancers that have worsened despite all approved treatments or when no suitable treatments are available. Participants must be in good physical condition, agree to use effective birth control, and commit to the study schedule. Those who've had more than two chemo treatments for some cancers or recent other cancer therapies can't join.Check my eligibility
What is being tested?
The trial is testing Vudalimab (XmAb20717) on patients with specific advanced cancers of the reproductive organs and urinary system. It's an open-label Phase 2 study, meaning both researchers and participants know what treatment is being given, aiming to assess how well it works and its safety.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions seen with immunotherapy such as fatigue, skin reactions, inflammation of organs like the liver or lungs (hepatitis or pneumonitis), flu-like symptoms, hormonal gland issues (like thyroid dysfunction), and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened despite all suitable treatments.
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My cancer type has been confirmed through lab tests.
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I am 18 years old or older.
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I am willing and able to follow the study's schedule completely.
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My cancer has worsened despite all suitable treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am using a highly effective birth control method.
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My prostate cancer is advanced and not responding to hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR as assessed by RECIST 1.1 criteria (efficacy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: vudalimabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,603 Total Patients Enrolled
1 Trials studying Prostate Cancer
78 Patients Enrolled for Prostate Cancer
ICON plcIndustry Sponsor
80 Previous Clinical Trials
24,996 Total Patients Enrolled
1 Trials studying Prostate Cancer
374 Patients Enrolled for Prostate Cancer
Barbara Hickingbottom, MDStudy DirectorXencor, Inc.
6 Previous Clinical Trials
468 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the U.S. Food and Drug Administration granted authorization for XmAb20717?

"Our experts at Power assigned XmAb20717 a score of 2 since there is evidence to suggest its safety, but no clinical results back up its efficacy."

Answered by AI

Is enrollment for this trial still available to those seeking treatment?

"According to the data on clinicaltrials.gov, this medical trial is actively seeking participants. It was originally posted on July 21st 2022 and updated most recently on July 19th of that same year."

Answered by AI

To what extent is participation in this research project being observed?

"To execute this research, ICON plc needs to acquire 150 suitable patients. The two trial locations are Valkyrie Clinical Trials (Los Angeles) and Comprehensive Cancer Centers of Nevada-Southern Hills (Las Vegas)."

Answered by AI

Who else is applying?

What site did they apply to?
Winship Cancer Institute, Emory University
What portion of applicants met pre-screening criteria?
Did not meet criteria
~53 spots leftby Mar 2025